Clare Brennan1,2,3,4, Hannah Whillis1,2,3,4, Choy Man1,2,3,4, Brian Wynne1,2,3,4, Vani Vannappagari1,2,3,4. 1. Dr. Brennan and and Ms. Man are with Clinical Development. 2. Dr. Vannappagari is with Epidemiology and Real World Evidence at ViiV Healthcare in Research Triangle Park, North Carolina. 3. Ms. Whillis was with GlaxoSmithKline, plc, in London, England, at the time of this work. 4. Dr. Wynne is with Global Medical Affairs at ViiV Healthcare in Collegeville, Pennsylvania.
Abstract
Objective: Increased rates of suicidal ideation/behavior have been reported in individuals with human immunodeficiency virus infection/acquired immunodeficiency syndrome. The electronic Columbia-Suicidality Severity Rating Scale (eC-SSRS™) is a validated tool for assessment of suicidal risk. The objective of this study was to assess the site perspectives on implementation of the eC-SSRS used in Phase IIIb studies of dolutegravir. Methods: We developed and validated the ViiV eC-SSRS Metrics and Perspectives Site Questionnaire (VEQ). Topics included ease of eC-SSRS administration, agreement with clinical assessment, unreported risk, and confidence in utility of the eC-SSRS. Results: Clinical data from two Phase IIIb studies were reviewed for correlation with the eC-SSRS results. The overall VEQ response rate was 83%. A total of 85% of respondents administered the eC-SSRS by phone, and 34% reported their patients would be unable to complete a web survey. First-time eC-SSRS users made up 64% of the responders; 85% of repeat administrators said implementation became easier over time. One-half said the eC-SSRS accurately predicted risk, and 14% said the eC-SSRS identified previously unreported risk. A total of 65% were somewhat/very confident their patients are being assessed accurately for suicide risk. Conclusion: Results of the eC-SSRS from ARIA and STRIIVING were consistent with the clinical data. The eC-SSRS identified previous unreported risk for suicidality and provided physicians opportunity for follow-up. Respondents felt the eC-SSRS helps them manage suicide risk, and they reported that its administration became easier with experience. Thus, the eC-SSRS is considered a useful tool in this setting.
Objective: Increased rates of suicidal ideation/behavior have been reported in individuals with human immunodeficiency virus infection/acquired immunodeficiency syndrome. The electronic Columbia-Suicidality Severity Rating Scale (eC-SSRS™) is a validated tool for assessment of suicidal risk. The objective of this study was to assess the site perspectives on implementation of the eC-SSRS used in Phase IIIb studies of dolutegravir. Methods: We developed and validated the ViiV eC-SSRS Metrics and Perspectives Site Questionnaire (VEQ). Topics included ease of eC-SSRS administration, agreement with clinical assessment, unreported risk, and confidence in utility of the eC-SSRS. Results: Clinical data from two Phase IIIb studies were reviewed for correlation with the eC-SSRS results. The overall VEQ response rate was 83%. A total of 85% of respondents administered the eC-SSRS by phone, and 34% reported their patients would be unable to complete a web survey. First-time eC-SSRS users made up 64% of the responders; 85% of repeat administrators said implementation became easier over time. One-half said the eC-SSRS accurately predicted risk, and 14% said the eC-SSRS identified previously unreported risk. A total of 65% were somewhat/very confident their patients are being assessed accurately for suicide risk. Conclusion: Results of the eC-SSRS from ARIA and STRIIVING were consistent with the clinical data. The eC-SSRS identified previous unreported risk for suicidality and provided physicians opportunity for follow-up. Respondents felt the eC-SSRS helps them manage suicide risk, and they reported that its administration became easier with experience. Thus, the eC-SSRS is considered a useful tool in this setting.
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